The Latest Cardiac and Vascular News
BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that UnitedHealthcare now covers the HeartFlow® FFRct Analysis, extending access to their 45 million beneficiaries. With this new coverage, more than 235 million people in the United States now have access to the HeartFlow Analysis — significantly advancing HeartFlow’s mission of transforming cardiovascular care. The […]
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]
Advanced Bifurcation Systems (“ABS” or the “Company”), a clinical stage medical device company developing an innovative stenting platform which overcomes the limitations of current approaches for the treatment of bifurcation lesions in coronary angioplasties, today announced that ABS, through its wholly-owned Canadian subsidiary, Advanced Bifurcation Systems Canada, Inc. (“ABS Canada”) has […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has appointed Jeffry Fecho as the Company’s Chief Quality Officer, effective as of June 25, 2018 (the “Effective Date”). John Onopchenko, Chief Executive Officer of Endologix, […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in […]
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cardurion Pharmaceuticals, a biotechnology company focused on the development of novel, next-generation therapeutics for the treatment of cardiovascular diseases, today announced that it has assembled world-class Scientific and Clinical Advisory Boards. “Cardiovascular disease is the leading cause of death in both men and women and accounts for one-third […]
REDWOOD CITY, Calif., June 26, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that several physicians have successfully treated over 40 patients in the US across 13 sites with the next-generation Pantheris image-guided atherectomy system for the treatment […]
SOUTH SAN FRANCISCO, Calif., June 26, 2018 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced that the first patient has been dosed in the company’s Phase 3 EXPLORER-HCM clinical trial. The pivotal study is […]
KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc. today announces data which indicates its HART CAD and HART CVE tests accurately diagnose Coronary Artery Disease (CAD) and risk for Major Adverse Cardiac Events (MACE) in Diabetic Mellitus (DM) patients. Researchers believe the data, presented on June 24 at the American Diabetes Association 2018 Scientific Sessions, […]
